At patient-focused drug development meeting, many patients explained that opioids gave them functionality versus side effects such as suicidal ideation and fatigue that come with other treatments.
US FDA Commissioner Scott Gottlieb has positioned combatting opioid epidemic as a top priority during his tenure as head of the agency, but testimony from chronic pain patients shed light on how difficult it is for both drugmakers to develop alternative treatments and for FDA to best regulate opioid use.
Speaking at a July 9 meeting about patient-focused drug development for chronic pain, several patient speakers shared anecdotes decrying the...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
